Posts by James Gianoutsos and Rod Beuzeval

About the Author

James Gianoutsos
Founder & President
RIMSYS Regulatory Management Software
https://www.rimsys.io

James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants.

James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs.

James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.




Rod Beuzeval
Director
Meddev Solutions
https://www.meddevsolutions.co.uk

Rod has worked in Pharmaceutical and Medical Device sectors for over 19 years and holds a degree in engineering. Rod has earnt Global Regulatory Affairs Certification from the Regulatory Affairs Professional Society.

His expertise lies in providing regulatory guidance to support new product development, worldwide registration and compliance activities. Rod is able to train large groups in the global regulatory requirements as well as QMS. He has years of hands-on experience of industry standards and regulation such as ISO 13485, ISO 14971, ISO 10993, IEC 60601-1, IEC 62304, IEC 62366, MDD 93/42/EEC, 21CFR, CMDCAS (MDSAP) amongst others.

He has registered devices in over 30 countries including EU, US, Canada, Japan, China, Russia, Kingdom of Saudi Arabia, South Korea and Latin America. Prior to forming Meddev Solutions, he was a Client Manager for a leading European Notified Body, conducting assessments of QMS for 13485 certification. Rod is still actively engaged with Notified Bodies, performing audits on their behalf and providing technical expertise.